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| Name | Class |
|---|---|
| Presbyterian Healthcare Services | UNKNOWN |
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The purpose of this study is to determine whether the addition of simple hand mobility and grip strengthening exercises to the usual care for upper extremity lymphedema will reduce limb volume and improve the quality of life, hand dexterity, and grip strength for those experiencing breast cancer-related lymphedema. Researchers will compare those receiving the usual treatment to those receiving the usual treatment plus hand mobility and grip strengthening exercises.
The purpose of this study is to determine whether the addition of simple hand mobility and grip strengthening exercises to the usual care for upper extremity lymphedema will reduce limb volume and improve the quality of life, hand dexterity, and grip strength for those experiencing early, moderate, or late stage breast cancer-related lymphedema.
This study is an experimental clinical trial to determine the effectiveness of hand mobility and grip exercises on limb volume, quality of life, hand dexterity, and grip strength in women with breast cancer-related lymphedema. The two independent variables are group, a between-subject factor, and time, a within subject factor. There are two levels of the independent variable of group: (1)usual care plus hand exercises and (2) usual care alone. The independent variable of time will be assessed at three timepoints: initial to 4 weeks, 4 to 8 weeks, and initial to 8 weeks of intervention. The four dependent variables are: (1) upper limb volume, (2) quality of life, (3) hand dexterity, and (4) grip strength. If a relationship (r>0.5) is found between any of the dependent variables, MANOVA will used for analysis. If no relationship is found, a 2x3 mixed ANOVA will be used to analyze each dependent variable without a significant relationship to the others. The comparison group will receive the usual physical or occupational therapy treatment, including compression bandaging, manual lymphatic drainage, shoulder and scapular muscle exercises, and education regarding skin hygiene and monitoring. The experimental group will receive the usual treatment plus additional hand mobility and grip strengthening exercises.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Participants will receive hand mobility and grip strengthening exercises in addition to the usual care for breast cancer-related lymphedema of the upper limb. |
|
| Comparison | Active Comparator | Participants will receive only the usual care for breast cancer-related lymphedema. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hand Mobility and Grip Strengthening Exercises | Other | Addition of hand mobility and grip strengthening exercises to the usual care for breast cancer-related lymphedema to assess changes in limb volume, quality of life, and hand function. |
| Measure | Description | Time Frame |
|---|---|---|
| Upper Limb volume | Circumferential measurements of the upper limb, converted to volumetric measurements with frustrum equation through Epic EMR. | Day 1, at 4 weeks, at 8 weeks of treatment/completion of study. |
| Measure | Description | Time Frame |
|---|---|---|
| Grip Strength | Grip Strength assessed with Jamar Hand Dynamometer. | Day 1, at 4 weeks, and at 8 weeks of treatment/completion of study. |
| Nine-Hole Peg Test | Nine-Hole Peg Test with affected limb only to assess dexterity. |
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Inclusion Criteria:
Exclusion Criteria:
Biologic women due to increased prevalence of breast cancer diagnosis.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elisabeth Wise, DPT | Contact | 505-772-1770 | EWise@phs.org | |
| Tiffany Ryan, MOT/R | Contact | 505-772-1775 | TRyan3@phs.org |
| Name | Affiliation | Role |
|---|---|---|
| Elisabeth Wise, DPT | Texas Woman's University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Presbyterian Healthplex | Recruiting | Albuquerque | New Mexico | 87109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33787821 | Background | Ahmad FB, Anderson RN. The Leading Causes of Death in the US for 2020. JAMA. 2021 May 11;325(18):1829-1830. doi: 10.1001/jama.2021.5469. No abstract available. | |
| 19001331 | Background | Ahmed RL, Prizment A, Lazovich D, Schmitz KH, Folsom AR. Lymphedema and quality of life in breast cancer survivors: the Iowa Women's Health Study. J Clin Oncol. 2008 Dec 10;26(35):5689-96. doi: 10.1200/JCO.2008.16.4731. Epub 2008 Nov 10. |
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No plan to share IPD with other researchers.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 11, 2023 | Jul 20, 2023 |
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Two groups will be compared, with treatment occurring at the same time. One group will receive the experimental exercises plus the usual treatment, the comparison group will only receive the usual treatment for breast cancer-related lymphedema.
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Participants will be masked regarding whether they are assigned to the intervention or comparison group.
| Usual Care | Other | Manual lymphatic drainage, compression, exercise, skin hygiene. |
|
| Day 1, at 4 weeks, and at 8 weeks of treatment/completion of study. |
| Lymphedema Life Impact Scale | Participants fill out Lymphedema Life Impact Scale, a self-report survey to assess quality of life. | Day 1, at 4 weeks, and at 8 weeks of treatment/completion of study. |
| Presbyterian Southern Outpatient Rehab | Recruiting | Rio Rancho | New Mexico | 87124 | United States |
|
| Presbyterian Santa Fe Medical Center | Recruiting | Santa Fe | New Mexico | 87507 | United States |
|
| 26618096 | Background | Chromy A, Zalud L, Dobsak P, Suskevic I, Mrkvicova V. Limb volume measurements: comparison of accuracy and decisive parameters of the most used present methods. Springerplus. 2015 Nov 19;4:707. doi: 10.1186/s40064-015-1468-7. eCollection 2015. |
| 32589208 | Background | Davies C, Levenhagen K, Ryans K, Perdomo M, Gilchrist L. Interventions for Breast Cancer-Related Lymphedema: Clinical Practice Guideline From the Academy of Oncologic Physical Therapy of APTA. Phys Ther. 2020 Jul 19;100(7):1163-1179. doi: 10.1093/ptj/pzaa087. |
| 25595999 | Background | De Groef A, Van Kampen M, Dieltjens E, Christiaens MR, Neven P, Geraerts I, Devoogdt N. Effectiveness of postoperative physical therapy for upper-limb impairments after breast cancer treatment: a systematic review. Arch Phys Med Rehabil. 2015 Jun;96(6):1140-53. doi: 10.1016/j.apmr.2015.01.006. Epub 2015 Jan 13. |
| 28206826 | Background | Feys P, Lamers I, Francis G, Benedict R, Phillips G, LaRocca N, Hudson LD, Rudick R; Multiple Sclerosis Outcome Assessments Consortium. The Nine-Hole Peg Test as a manual dexterity performance measure for multiple sclerosis. Mult Scler. 2017 Apr;23(5):711-720. doi: 10.1177/1352458517690824. Epub 2017 Feb 16. |
| 31001613 | Background | Giray E, Akyuz G. Assessment of Family Caregiver Burden and Its Relationships Between Quality of Life, Arm Disability, Grip Strength, and Lymphedema Symptoms in Women with Postmastectomy Lymphedema: A Prospective Cross-Sectional Study. Eur J Breast Health. 2019 Feb 15;15(2):111-118. doi: 10.5152/ejbh.2019.4385. eCollection 2019 Apr. |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D000072656 | Breast Cancer Lymphedema |
| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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